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A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma (ASCT)

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ClinicalTrials.gov Identifier: NCT01969942
Recruitment Status : Withdrawn (No subjects meeting study inclusion were enrolled.)
First Posted : October 25, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Brief Summary:

The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient]) matched related or unrelated donors. Specifically, we will examine:

  • The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
  • The incidence of transplant related mortality at 100 days.

Condition or disease Intervention/treatment Phase
Ewing Sarcoma Biological: allogeneic stem cell transplantation Drug: Clyclophosphamide Drug: Fludarabina Drug: Busulfan Drug: Melphalan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma
Study Start Date : April 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: allogeneic stem cell transplantation Plan A
Subjects will receive the vaccine, Busulfan and Melphalan.
Biological: allogeneic stem cell transplantation Drug: Busulfan Drug: Melphalan
Experimental: allogeneic stem cell transplantation Plan B
If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.
Biological: allogeneic stem cell transplantation Drug: Clyclophosphamide Drug: Fludarabina



Primary Outcome Measures :
  1. Development of Grade 3-4 GVHD [ Time Frame: 12 months ]


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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 0-30 years with relapsed or therapy refractory Ewings sarcoma, excluding patients with brain metastases. Patients who have received a prior autologous stem cell transplant are eligible.
  • Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient.

Exclusion Criteria:

  • Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:

    • Cardiac: Ejection Fraction less than 50 percent
    • Renal: Est. Creatinine Clearance less than 50
    • Hepatic: Bilirubin greater than 3.0
    • Pulmonary: Diffusing Capacity for Carbon Monoxide (DLCO) less than 70 percent, or for patient who cannot cooperate with pulmonary function testing, O2 saturation less than 95 percent on room air.
  • Performance status: Lansky performance less than 70; Eastern Cooperative Oncology Group (ECOG) status greater than or equal to 2
  • Patients with an isolated recurrence of their tumor (in the site of primary tumor) greater than 1 year after completing therapy are excluded as these patients could be cured with local therapy alone.

    • As part of the standard of care for pre-transplant evaluation subjects will be tested for exposure to viral agents such as hepatitis B, C, HTLV-1/2 and HIV. Subjects testing positive for HI may be rejected as candidates for transplantation, based on the clinical judgement of the stem cell transplant physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969942


Locations
United States, Kentucky
Pediatric Hematology/Oncology University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Kenneth Lucas, M.D. University of Louisville

Additional Information:
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01969942     History of Changes
Other Study ID Numbers: 13.0176
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by University of Louisville:
Ewings sarcoma

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Melphalan
Busulfan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs